10 July 2020 - - The US Food and Drug Administration has accepted a supplemental New Drug Application and granted Priority Review for Brilanta (ticagrelor) for the reduction of subsequent stroke in patients who experienced an acute ischemic stroke or transient ischemic attack, British-Swedish-based AstraZeneca (OTC: AZNCF) said.

The Prescription Drug User Fee Act date, the FDA action date for this supplemental application, is scheduled for the fourth quarter of 2020.

The sNDA was based on results from the Phase III THALES trial, which showed aspirin plus Brilanta 90mg used twice daily for 30 days, resulted in a statistically significant and clinically meaningful reduction in the risk of the primary composite endpoint of stroke and death, compared to aspirin alone.

The results were in line with the known safety profile of Brilanta.

The data from the THALES trial will be published in a peer-reviewed journal and presented at an forthcoming medical congress.

Brilanta is not indicated in patients with minor acute ischemic stroke or high-risk transient ischemic attack.

Brilanta is approved in more than 110 countries for the prevention of atherothrombotic events in adult patients with acute coronary syndrome and in more than 70 countries for the secondary prevention of cardiovascular events among high-risk patients who have experienced a heart attack.

In May 2020, the Food and Drug Administration approved a label update for Brilanta in the US to include the reduction of the risk of a first heart attack or stroke in high-risk patients with coronary artery disease.